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Tag: FDA

September 16, 2022 stevensevert2

FDA Issues New Draft Guidance on Medical Device Quality System Software Assurance

September 2, 2022 stevensevert2

The State of Pharmaceutical Quality FY21

July 27, 2022July 27, 2022 stevensevert2

FDA Releases New Draft Guidance for Remote Regulatory Assessments

July 1, 2022July 27, 2022 stevensevert2

FDA Virtual Inspections Are Here to Stay – And That’s a Good Thing

February 23, 2022July 23, 2022 stevensevert2

After Years of Delays, FDA Finally Issues Proposed Rule to Harmonize QSR to ISO 13485

February 4, 2022February 23, 2022 stevensevert2

Is My Product a Medical Device?

November 28, 2021August 20, 2022 stevensevert2

Free Whitepaper: Clause-by-Clause Explanation of ISO 13485:2016

FMEAQuest from IntellaQuest is hands down the best FMEA software on the market. If you're looking for an FMEA software solution to start automating your FMEA and control plan creation or you're trying to move away from unwieldy, non-user-friendly software like AIAG CTS, you owe it to yourself to take a look at FMEAQuest. Quality spill? Let us help clean it up so you can know that your customers are protected and can focus on doing what you do best, making cool things. #3rdpartysorting #qualitycontrol #qualityinspection #manufacturing #machining #automotive #automotivemanufacturing #isometricconsulting #isometricqualitysolutions Are you looking to fill Quality Engineering positions in your organization? Let us help. We offer a full range of services, including recruiting services for quality professionals. With decades of relevant experience, we know how to find great candidates with the right experience to meet your particular quality needs. #recruiting #qualityengineering #qualityengineers #hiring #HR #positionfilled #qualityprofessionals #IsometricConsulting #IsometricQualitySolutions Here's hoping that everyone is having a fun and safe 4th of July weekend! We do everything that we can to prevent it, but let's face it, sometimes we have an escape of nonconforming material. When that happens, count on us to help keep your customers protected. With decades of automotive industry experience, we understand how to properly contain a spill of nonconforming material. We offer onsite sorting services at your facility or your customer's facility to minimize any impact to your customer's production and to restore confidence in your organization and product. #3rdpartysorting #sorting #inspection #qualitycontrol #nonconformingmaterial #automotive #automotiveindustry #IATF16949 #IsometricConsulting #IsometricQualitySolutions "Without a standard, there is no logical basis for making a decision or taking action." - Joseph M. Juran Are you looking for an exciting opportunity for project-based quality control work in manufacturing environments in West Central Ohio and Eastern Indiana? We're looking for a Quality Control Supervisor and Technicians to build our sort teams to complete quality control projects in plants in the area. DM or reach out to Steven Severt for more information! #qualitycontrol #quality #QC #sorting #manufacturing #inspection #automotivemanufacturing #isometricconsulting #isometricqualitysolutions Are you a Midwest manufacturer looking for a partner to help with your sorting and quality control needs? We've been at work developing a new quality sorting service to help you keep your customers protected. Reach out if you'd like more info! #sorting #qualitycontrol #automotivemanufacturing #ISO9001 #IATF16949 Looking to become an ISO 9001 Lead Implementer? You'll need globally recognized training.
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